Cleared Traditional

K982545 - BMP CABLE SYSTEM (FDA 510(k) Clearance)

K982545 · Biomet, Inc. · Orthopedic device

Oct 1998

Decision

90d

Days

Class 2

Risk

K982545 is an FDA 510(k) clearance for the BMP CABLE SYSTEM. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 19, 1998, 90 days after receiving the submission on July 21, 1998.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K982545 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 21, 1998
Decision Date	October 19, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF